Feasibility Study of the AffloVest in Bronchiectasis

NCT04266873 | Suspended FDA Device

• 1 other identifier: PO2552
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility study of High Frequency Chest Wall Oscillation (HFCWO) using the AffloVest in 30 patients with Bronchiectasis over a 6 week period. Outcome measures include lung function, quality of life questionnaire, High resolution computed Tomography and visual analogue scale for ease of clearance.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• High Resolution Computed Tomography (HRCT)

  HRCT will be done at full inspiration and full expiration and reviewed by two independent radiographers who will be blinded to timepoint and participant. Radiographers will then use the Brody score to give the scans a score reflecting any changes to sputum volume or otherwise from intervention. Scans will be done and reviewed at baseline, three weeks of intervention and six weeks of intervention

  6 weeks

Secondary Outcomes (3)

• Forced Expiratory Volume at 1 second (FEV1)

  6 weeks

• Visual Analogue Score for ease of sputum expectoration (VAS)

  6 weeks

• Quality of Life in Bronchiectasis questionnaire (QOL-B)

  6 weeks

Study Arms (1)

AffloVest HFCWO intervention

EXPERIMENTAL

Use of the AffloVest for 30 mins, twice a day for 6 weeks

Device: AffloVest

Interventions

AffloVest DEVICE

Form of High Frequency Chest Wall Oscillation mimicking manual techniques on a patients thorax to assist with secretion clearance. Delivered for 30 minutes, twice a day

AffloVest HFCWO intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and females 18 years or over
• Current diagnosis of bronchiectasis
• Productive of sputum on a daily basis
• Clinical stability over a 2 week period prior to enrolment

You may not qualify if:

• Cystic fibrosis
• Severe obstructive airways disease (defined as FEV1 less than 25 percent)
• Predominant lung disease is not bronchiectasis in the opinion of the investigator (e.g. asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis)
• Bronchiectasis in only 1 lobe
• Currently treated non-tuberculous mycobacterial lung disease
• Acute congestive cardiac failure
• Contra-indication or unable to perform HRCT imaging, including pregnancy
• Contra-indication to using AffloVest including lung malignancy, recent rib fractures, radiological evidence of lung cavitation, and recent significant haemoptysis (in the opinion of the investigator)
• History of poor adherence to physiotherapy treatment
• Cognitive or memory problems affecting ability to follow instructions or give informed consent

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Papworth Hospital NHS Trust

Cambridge, CB2 0AY, United Kingdom

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: CT scans will be anonymised before being sent to Radiographer to Brody score
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Feasibility interventional study using intervention for 6 weeks

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 12, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)